Boston Scientific’s (BSX) decision earlier this week to present only the acute procedural safety results of the PREVAIL clinical trial on the effectiveness of the Watchman device has stirred rumors in the medical devices space. According to the market rumor, the company’s plan for a limited release indicates the probability of failure of some of the results to meet the suitable outcome, which Boston Scientific may not want to present.
Consequently, the company made another announcement stating that the PREVAIL clinical trial results presentation will include all three co-primary endpoints, showing safety and efficacy of Watchman. Notably, the preliminary results of the PREVAIL Trial will be disclosed on Mar 9 at the American College of Cardiology in California.
The PREVAIL trial is a study on the Watchman Left Atrial Appendage Closure device, which is used to reduce chances of stroke. Apart from the earlier stated endpoint of acute occurrence of death, ischemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention, the other two endpoints are comparison of composite of stroke, systemic embolism, cardiovascular or unexplained death (at 18 months follow-up) and comparison of ischemic stroke or systemic embolism (occurring from greater than 7 days post randomization to 18 months follow-up).
The company plans to submit the results from the PREVAIL confirmatory study to the U.S. Food and Drug Administration (:FDA) for approval.
Although Boston Scientific has changed its decision and is releasing all three endpoints of the study, we remain skeptical until more visibility is obtained on the matter. The headwinds troubling Boston Scientific’s core segments have affected the company’s business. However, to revive its top line, Boston Scientific is focusing on strategic initiatives to drive growth and profitability. These include restructuring initiatives, strengthening its portfolio, targeting suitable acquisitions in areas of unmet medical needs and focusing on emerging markets.
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